Analysis of the Structural Changes of Adverse Drug Reaction Reports in China
10.3870/j.issn.1004-0781.2025.06.024
- VernacularTitle:我国药品不良反应报告结构变动分析
- Author:
Yingni HUANG
1
;
Guangxing MENG
1
;
Yanxiang LI
1
Author Information
1. 广东药科大学医药商学院,中山 528400;国家药品监督管理局药物警戒技术研究与评价重点实验室,中山 528400
- Publication Type:Journal Article
- Keywords:
Adverse drug reaction report;
Structural change analysis;
Adverse drug reaction monitoring;
Drug safety
- From:
Herald of Medicine
2025;44(6):982-988
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the structural changes and potential improvement in the reporting system,and to provide reference for improving the efficiency of drug safety supervision.Methods Descriptive statistical analysis and structural analysis were used to analyze the source of adverse drug reaction(ADR)reports,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China from 2014 to 2023.Results The structural variation of the source of ADR report,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China were 20.00%,6.20%,27.20%,9.40%and 16.62%,respectively.Among them,patients aged 65 and over(VSV=13.20)had the largest change value and positive change;the source of drug business enterprises(VSV=-9.70),intravenous injection route(VSV=-6.51)and traditional Chinese medicine category(VSV=-4.70)showed negative changes.Conclusions It is necessary to improve the laws and regulations of the industry,enhance the ability of enterprises to implement the main responsibility,improve the public's awareness and participation awareness of ADR,strengthen the monitoring and guidance strategies of drug safety in specific age groups,improve the monitoring level of adverse reactions of traditional Chinese medicine,and strengthen the supervision of adverse reactions of intravenous injection.
